Quantitative Diagnosis of Liver Fibrosis on Multiparametric MRI

N/AEnrolling By InvitationNCT03176797

Zhujiang Hospital300 enrolled

Overview

Early diagnosis and treatment of liver fibrosis can repress or delay the development of cirrhosis and hepatocellular carcinoma. The purpose of this pilot study is to evaluate non-invasive multiparametric magnetic resonance imaging (MRI) techniques in the detection and grading of liver fibrosis, so that patients can be treated in time. These techniques combined could reach high diagnostic performance for detection of liver fibrosis, and could decrease the number of liver biopsies.

Early diagnosis and treatment of liver fibrosis can repress or delay the development of cirrhosis and hepatocellular carcinoma. While liver biopsy is still considered the gold standard for diagnosing and assessing the presence and degree of liver fibrosis and inflammation, it has disadvantages including the potential for sampling error and risk of complications. New imaging modalities such as diffusion weighted imaging (DWI), intravoxel incoherent motion (IVIM), diffusion kurtosis imaging (DKI), T1ρ relaxation time (T1ρ), T1 mapping of pre-contrast and hepatocyte phase using hepatocyte specific agent and susceptibility weighted imaging (SWI) allow non-invasive evaluation of liver parenchymal characteristics and may be able to detect and quantify parenchymal fibrosis alleviating the need for biopsy. Patients with chronic liver disease or normal liver parenchyma who are scheduled to undergo either liver resection or liver biopsy are included. Referred patients undergo multiparametric MRI including DWI, IVIM, DKI, T1ρ, T1 mapping of pre-contrast and hepatocyte phase and SWI before surgery or biopsy. The pathologic changes are evaluated using multiparametric MRI, and compared between normal/early fibrosis and advanced fibrosis. To explore if combine these techniques could reach higher diagnostic performance for detection and grading of liver fibrosis. This project will provide a reliable and noninvasive method for the monitoring stage of liver fibrosis and therapeutic evaluation.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

300

Conditions

Liver Fibrosis Cirrhosis

Interventions

Liver MRIDIAGNOSTIC_TEST

Liver MRI including DWI, IVIM, DKI, T1ρ, T1 mapping of pre-contrast and hepatocyte phase and SWI.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * chronic liver disease (viral hepatitis, alcoholic hepatitis, or other...) * AND willingly able to complete all research procedures and follow the entire research process * AND scheduled for liver resection or biopsy * AND signed informed consent Exclusion Criteria: * Any contraindication for contrast-enhanced MRI * Pregnant or nursing women * Any organ transplant history, and existing functional grafts (except corneal or fur grafts) * Recent right upper quadrant patients with traumatic healed * A serious history of illness or other evidence of a serious illness or suffering from any other disease * Patients who have been enrolled in other interventional clinical trials

Locations (1)

ZhuJiang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

MRI T1ρ T1mapping SWI and DWI

Quantitative Diagnosis accuracy of MRI in the degree of fibrosis and advanced fibrosis compared with histology

Time frame: MRI within 3 months of liver biopsy or surgery

Secondary Outcomes

MRI T1ρ T1mapping SWI and DWI

Quantitative Diagnosis accuracy of MRI in the degree of fibrosis and advanced fibrosis compared with serological markers.

Time frame: Blood Test taken on same day as MRI

Data from ClinicalTrials.gov

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